Background Post hoc analyses of belimumab BLISS trials identified baseline factors generally associated with high disease activity as predictors of improved response to treatment, such as SELENA-SLEDAI (SS)> 10, low complement levels, anti-dsDNA positivity and glucocorticoid therapy.
Objectives We examined clinical outcomes in patients with high disease activity treated with belimumab in U.S. clinical practice settings in 2012.
Methods OBSErve (BLM117295) is a multicenter retrospective medical chart review study. 92 rheumatologists from U.S. non-academic centers who treat >10 SLE patients annually and have >5 years of practice experience were randomly recruited. Physicians randomly identified adult SLE patients who had received ≥8 infusions of belimumab as part of usual-care. Index date is the first belimumab infusion date. This post-hoc analysis was conducted among patients with low complement and high anti-dsDNA, steroids ≥7.5mg/day, and SS>10 at index date. Results were reported for the 3 subgroups and the entire sample. The primary outcome was the change in overall SLE disease manifestations 6 months after index date based on physician judgement. Changes from index date in SS and oral steroid dose (when available at index date) were also analyzed.
Results 501 eligible patient charts were abstracted. Key patient characteristics at index date were mean age 41.3 yrs; female 89%; Caucasian 53%, black/African American 24%, Hispanic 18%; and SLE disease duration≤5yrs 56%. 50% (n=252) had hypocomplementemia and high anti-dsDNA, 69% (n=347) had steroid dose≥7.5mg/day, and 86 (70%) out of 122 with available SS had SS>10 at index date.
Physician impression of overall change in disease manifestations over 6 months was similar in the subgroups of high disease activity compared to the entire sample. Within the 3 subgroups, mean SS scores decline ranged from 6.8-7.5 (51-53%), and mean steroid reduction ranged from 11.5-15.0 mg/day (58-61%) over 6 months.
Conclusions Among the SLE patients with markers of high disease activity treated with at least 6 months of belimumab in clinical practice settings, clinicians observed improvement in overall SLE clinical manifestations, reduction in SELENA-SLEDAI, and reduction in steroid dose 6 months after belimumab initiation with no control arm.
Disclosure of Interest H. Kan Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, C. Collins Consultant for: GlaxoSmithKline, M. Dall’Era Consultant for: GlaxoSmithKline, M. McGuire Grant/research support from: GlaxoSmithKline, V. Koscielny Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, R. Pappu Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, C. Molta Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline